Vitamin D DeficiencyNCT05009498
Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery
A study testing Vitamin D3 supplementation in people with Vitamin D Deficiency and Rotator Cuff Tears, run by Community Memorial Health System at 2 sites in United States.
Trial summary
Rotator cuff injuries are the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Rotator cuff repair has long been the mainstay of treatment for symptomatic full-thickness tears and medium to large partial thickness tears that do no improve with nonoperative therapies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Rotator Cuff Tears
- What is being tested?
- Vitamin D3 supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acute or chronic rotator cuff tear
- Small to medium sized rotator cuff tear
- Rotator cuff tear which can be treated with arthroscopic RCR (single or double row technique)
- Serum 25(OH)D levels < 30 ng/mL
Who cannot join
- Massive rotator cuff tear that is inoperable or requires superior capsular reconstruction (SCR)
- Revision RCR
- Serum 25(OH)D levels ≥ 30 ng/mL
- Elevated serum calcium (> 10.5 mg/dL)
- Known or likely undiagnosed disorders of bone metabolism (i.e. Pagets, ostemalacia, osteopetrosis, OI, etc.)
- History of hyperhomocysteinemia
Show all 10Show fewer
- Vitamin D allergy or other contraindication to Vitamin D supplementation
- Patients currently taking OTC multivitamin that contains Vitamin and unwilling/unable to discontinue use for the duration of this study
- Patient who are pregnant or plan to become pregnant in the next two years
- In the judgment of the investigators, patients who will have trouble adhering to the study follow-up schedule or dosing schedule
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Community Memorial Health System
Ventura, California, 93003
Michael Bogard, DO, 714-465-7064, mbogard@cmhshealth.org
Ventura County Medical Center
Ventura, California, 93003
Michael Bogard, DO, 714-465-7064, mbogard@cmhshealth.org
About this study
Official title: Vitamin D3 Supplementation vs Placebo for Vitamin D Deficient/Insufficient Patients Undergoing Arthroscopic Rotator Cuff Repair: a Quadruple-blinded Randomized Controlled Trial
Rotator cuff injuries are the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Rotator cuff repair has long been the mainstay of treatment for symptomatic full-thickness tears and medium to large partial thickness tears that do no improve with nonoperative therapies.
Approximately 32% of the US population is Vitamin D deficient. This is important for many health reasons, but specifically, Vitamin D has been found to play a critical role in bone mineralization and fracture healing/prevention. There is emerging data to support Vitamin D's role in regulating the inflammatory response throughout the body, which includes soft tissue (i.e. tendons) healing. The role of Vitamin D in tendon to bone healing has yet to be fully investigated, yet it is reasonable to conclude that normal blood levels of Vitamin D would optimize the setting for healing in rotator cuff repair.
The investigators hypothesize that Vitamin D deficient patients undergoing shoulder rotator cuff repair will experience more positive outcomes and decreased complications when supplemented with Vitamin D3, compared to Vitamin D deficient patients who do not receive supplementation. The objective of this study is to demonstrate the positive effect of Vitamin D3 in rotator cuff repair healing and patient reported outcomes in patients who are Vitamin D deficient
Read the detailed description
Rotator cuff pathology is the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Incidence increases in a direct relationship to age. It is reported that over the age of 60, 28% of patients had full-thickness tears and 26% had partial thickness tears. Increasing age, history of trauma and hand dominance are associated risk factors for rotator cuff tearing. Rotator cuff tears (RCT) can occur from a degenerative process that increases with age, but also associated with micro- or macrotrauma. Rotator cuff repair (RCR) has long been the mainstay treatment for symptomatic full-thickness tears and medium to large partial thickness tears that have failed conservative measures. Long term clinical results for rotator cuff repair exceed 90% good to excellent results at 10 years.
According to the National Center for Health Statistics, approximately 32% of the US population is Vitamin D deficient. It has been widely accepted and studied that Vitamin D (25OHD) plays an important role in bone mineralization and fracture healing/prevention. Also, numerous studies have discovered the association of Vitamin D insufficiency with non-skeletal conditions such as Type 2 diabetes mellitus, cardiovascular disease, chronic pulmonary disease, tuberculosis, and upper respiratory conditions. There is an emerging focus on the role of Vitamin D and soft tissue healing and function.
Vitamin D decreases inflammation in the body by downregulating TNF alpha, which in turn decreases the amount of MMP-9 secreted. Increased MMPs have been associated with poor healing in rotator cuff muscles. Vitamin D levels have also been shown to affect the expression of BMPs, TGF-beta, and RANK.
Vitamin D receptors have been discovered on important soft tissue structures including tendons. It has been posited that Vitamin D's effect on regulating the inflammatory response is associated with tendon healing and overall function.
Traditional oral dosing for Vitamin D is in the Vitamin D3 form. Dosing quantities range from 400 IU to 5000 IU/day. In significantly deficient patients, it is not uncommon to see 50,000 IU/week for several weeks to achieve normal serum Vitamin D levels.
Studies have shown that the human body will generate up to 10,000-25,000 IU/day from sun exposure. This finding, among others, has called into question the arbitrary values set by IOM/ES to quantify serum levels for Vitamin D sufficient, insufficiency, or deficiency. Also, the daily recommended dosing quantities.
Vitamin D repletion therapy has been shown to be effective but often over protracted courses with no distinct linear relationship with the current recommendations set by the IOM/ES. Kerns et al 2014 performed the most comprehensive meta-analysis review of single, high-dose vitamin D supplementation and subsequent efficacy and safety. Their conclusion was that single vitamin D dosing of > 200,000 IU was able to sustain mean 25(OH)D concentrations > 30 ng/mL and there were no adverse effects noted at doses < 200,000. They also showed in all studies that peak serum 25(OH)D occurred at days 3-7. Some studies that examined single dose of 100,000 IU failed to achieve a serum 25(OH)D level of sufficiency for patients with baseline 25(OH)D of < 20ng/mL, and there were some reported adverse effects in single dose quantities of 300,000 to 600,000 IU (possible increased fracture risk, elevated bone turnover, transient serum hypercalcemia (> 500,000), and GI irritability).
With the prevalence of RCT and Vitamin D deficiency in the population, it is only reasonable to conclude that addressing the underlying biochemical processes to enhance soft tissue healing would provide a more favorable environment in the setting of rotator cuff repair. Orthopedic surgeons seek to optimize patient care by exhausting all available, and albeit reasonable, controllable variables The investigators hypothesize that Vitamin D deficient patients undergoing shoulder rotator cuff repair will experience more positive outcomes and decreased complications when supplemented with Vitamin D3, compared to Vitamin D deficient patients who do not receive supplementation.
The objective of this study is to demonstrate the positive effect of Vitamin D3 supplementation in rotator cuff repair healing and patient reported outcomes in patients who are Vitamin D deficient.
This is a prospective, quadruple-blinded, randomized, placebo-controlled study to evaluate the feasibility and effect of Vitamin D3 supplementation in Vitamin D deficient patients undergoing rotator cuff repair. Patients will be randomized to one of two arms, either Vitamin D3 supplementation or placebo. Each patient will be given a loading dose of 150,000 IUs prior to surgery, and then a bi-monthly maintenance dose of 50,000 IUs for one year. The patients will be followed for a total of 24 months following surgery. Clinical evidence of rotator cuff repair and patient reported outcome measures will be evaluated by chart review and patient questionnaires. All post-operative standard of care practices including laboratory tests, imaging, and rehabilitation will also be collected.
Enrollment will close once enough patients have been enrolled to achieve a 95% power. The investigators expect the study to take 2-3 years to complete.
Patients that meet all of the inclusion criteria and none of the exclusion criteria will be approached by the investigators, informed of the study, and provided with an informed consent form (ICF). Ample time will be given to the patient to review the ICF form in it's entirely and ask the investigator any questions they may have. If the patient agrees to participate, the will be asked to sign the ICF and the investigator obtaining consent will countersign. Patients will receive a copy of the signed consent form for their records, and the ICF will be scanned into the patient's medical record. The original paper copy of the ICF will be stored in a locked cabinet in the investigator's office. No data will be collected prior to completion of the informed consent form.
Once consent has been obtained, each participant will be assigned a subject ID number (ex. Subject # XXX). Baseline data will then be collected from the patient and their medical chart. These data points include: demographics, medical history, injury details, and rotator cuff tear pattern and location. A baseline patient reported outcomes questionnaire will also be obtained.
Feasibility of this study will be assessed over 24 months. Vitamin D3 and placebo will be administered over the course of the first 12 months of the study. Supplementation will begin between 3 and 7 days prior to the day of surgery, depending on the pre-operative scheduled appointment and relation to the day of surgery. The study participants will be expected to store and administer their scheduled dosing as instructed by the study team. Reminders prompting the patient's scheduled dosing will be sent via text and/or email, depending on patient preference as indicated on the initial questionnaire.
The loading dose and first maintenance dose following surgery will be administered to the patient at the study site. The bottle will then be provided to the participant for their personal storage and they will be instructed to take one 50,000 IU capsule (or identical placebo) once every two weeks for a total of 25 weeks (one year of total supplementation).
To ensure compliance, the participant will be asked to bring their bottle with them to each follow-up visit. At the 12 month follow-up visit, the participants will return their bottle to either the investigator or clinical research coordinator. If the participant does not return the bottle, the clinical research coordinator will provide them with an envelope to return it via mail.
Pre-operative labs will be ordered as standard of care and the results will be collected from the medical chart. Laboratory tests to be drawn are a comprehensive metabolic panel (CMP), serum 25(OH)D level, and complete blood count (CBC).
The study protocol does not dictate the surgical technique. Based on the study's eligibility criteria, all participants must receive tear pattern specific arthroscopic rotator cuff repair utilizing the double row versus single row technique. The orientation and final repair construct will be determined intraoperatively to the discretion of the treating surgeon. Surgical debridement, biceps tenotomy with or without tenodesis, and other surgical procedures will be performed as indicated for the benefit of the patient.
Details of the surgical management of the patient's rotator cuff tear will be collected from the medical record. Post-operative laboratory tests will be drawn per standard of care and collected from the medical record.
Post-operative rehabilitation will consist of sling utilization starting from post-operative day zero through week six, as per standard of care. Patients will be instructed on early passive range of motion (ROM) exercises (i.e. pendulum exercises) that will begin at the discretion of the treating surgeon. A recent study from AJSM (Keener et al, 2014) demonstrated no significant difference between early passive ROM vs 6 weeks of sling immobilization. The patient will be instructed to avoid active ROM (aROM) of the operative shoulder for the first 6 weeks, but will be allowed to remove the sling for elbow/wrist/hand ROM and hygiene. Starting at week one, patients will begin formal outpatient physical therapy (PT) twice a week. From weeks 6-12 patients will begin PT guided initiated assisted active ROM and aROM of the shoulder. From months 3-4, initiated cuff, deltoid, and scapular stabilizer strengthening. From month 4 and on, patients will begin full activities between months 4 through 6 on the basis of individual progress.
Details of the patient's rehabilitation course will be collected from the medical record The investigator who is the operative orthopedic surgeon will monitor patient safety for each of their patients involved in the study. The surgeon will be responsible for reviewing adverse events, enrollment numbers, and medical compliance. All serious adverse events will be recorded and promptly submitted according to the appropriate hospital policy. All serious adverse events will also be promptly reported to the IRB as well.
Following completion of this study, participants may be un-blinded from their treatment group upon request.
The patient questionnaires will be the primary data collection tool for the study. Other data points will be collected from the electronic medical record. Data will be stored on an encrypted database on password protected computers at the study site, only accessible to the investigators and study personnel. Data will be recorded at the time of collection. Hardcopy questionnaires and informed consent forms will be retained for double verification in a locked cabinet only accessible to the study team.
Study documents will be held in strict confidence by the investigators and other study personnel, and all efforts will be made to maintain patient confidentiality as per standard HIPAA requirements. All data will be de-identified prior to dissemination.
In accordance with 42 CFR 164.530(j)(2), all study records will be securely retained by the investigators for a minimum of 6 years following completion of the study
- Conditions
- Vitamin D Deficiency, Rotator Cuff Tears
- Being tested
- Vitamin D3 supplementation, Placebo
- Keywords
- Rotator Cuff repair, Rotator Cuff tears, Vitamin D deficiency, Vitamin D3 supplementation, Shoulder arthroscopy
- Medical subject headings
- Vitamin D Deficiency, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 supplementationDietary supplement
Vitamin D3 in 50,000 IU capsules Loading dose of 150,000 IUs (3 capsules) Interval dosing of 50,000 IUs (1 capsule) every 2 weeks for 1 year
PlaceboOther
Placebo capsule, identical in appearance to the Vitamin D3 supplement capsule Dosing intervals identical in duration and quantity as Vitamin D3 supplement group
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Patient will receive a placebo dosing, identical in appearance and at the same intervals as the interventional dose Receives: Other: Placebo |
| Vitamin D3 supplementation group | Active comparator | Patient will receive high-dose Vitamin D3 supplementation in capsule form, identical in appearance and at the same intervals as the placebo dose Receives: Dietary Supplement: Vitamin D3 supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of California-Los Angeles Shoulder score
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Measured: Baseline (Preop)
Constant-Murray Shoulder Score
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
Measured: Baseline (Preop)
American Shoulder and Elbow Surgeon score
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
Measured: Baseline (Preop)
SF-12 (12-item Short Form Survey)
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Measured: Baseline (Preop)
University of California-Los Angeles Shoulder score
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Measured: 6 weeks post op
Constant-Murray Shoulder Score
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
Measured: 6 weeks post op
American Shoulder and Elbow Surgeon score
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
Measured: 6 weeks post op
SF-12 (12-item Short Form Survey)
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Measured: 6 weeks post op
University of California-Los Angeles Shoulder score
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Measured: 12 weeks post op
Constant-Murray Shoulder Score
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
Measured: 12 weeks post op
American Shoulder and Elbow Surgeon score
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
Measured: 12 weeks post op
SF-12 (12-item Short Form Survey)
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Measured: 12 weeks post op
University of California-Los Angeles Shoulder score
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Measured: 6 months post op
Constant-Murray Shoulder Score
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
Measured: 6 months post op
American Shoulder and Elbow Surgeon score
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
Measured: 6 months post op
SF-12 (12-item Short Form Survey)
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Measured: 6 months post op
University of California-Los Angeles Shoulder score
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Measured: 12 months post op
Constant-Murray Shoulder Score
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
Measured: 12 months post op
American Shoulder and Elbow Surgeon score
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
Measured: 12 months post op
SF-12 (12-item Short Form Survey)
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Measured: 12 months post op
University of California-Los Angeles Shoulder score
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Measured: 24 months post op
Constant-Murray Shoulder Score
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
Measured: 24 months post op
American Shoulder and Elbow Surgeon score
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
Measured: 24 months post op
SF-12 (12-item Short Form Survey)
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Measured: 24 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Memorial Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bogard, Community Memorial Health System
- Investigators
- Michael Bogard, DO, Principal investigator, Community Memorial Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009498
- Sponsor's protocol ID
- VITD3RCR
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angeline ME, Ma R, Pascual-Garrido C, Voigt C, Deng XH, Warren RF, Rodeo SA. Effect of diet-induced vitamin D deficiency on rotator cuff healing in a rat model. Am J Sports Med. 2014 Jan;42(1):27-34. doi: 10.1177/0363546513505421. Epub 2013 Oct 16.
PubMed 24131579Oh JH, Kim SH, Kim JH, Shin YH, Yoon JP, Oh CH. The level of vitamin D in the serum correlates with fatty degeneration of the muscles of the rotator cuff. J Bone Joint Surg Br. 2009 Dec;91(12):1587-93. doi: 10.1302/0301-620X.91B12.22481.
PubMed 19949122Ryu KJ, Kim BH, Lee Y, Dan J, Kim JH. Low Serum Vitamin D Is Not Correlated With the Severity of a Rotator Cuff Tear or Retear After Arthroscopic Repair. Am J Sports Med. 2015 Jul;43(7):1743-50. doi: 10.1177/0363546515578101. Epub 2015 Apr 13.
PubMed 25868637Harada GK, Arshi A, Fretes N, Formanek B, Gamradt S, McAllister DR, Petrigliano FA. Preoperative Vitamin D Deficiency Is Associated With Higher Postoperative Complications in Arthroscopic Rotator Cuff Repair. J Am Acad Orthop Surg Glob Res Rev. 2019 Jul 3;3(7):e075. doi: 10.5435/JAAOSGlobal-D-19-00075. eCollection 2019 Jul.
PubMed 31579883Dougherty KA, Dilisio MF, Agrawal DK. Vitamin D and the immunomodulation of rotator cuff injury. J Inflamm Res. 2016 Jun 14;9:123-31. doi: 10.2147/JIR.S106206. eCollection 2016.
PubMed 27366101Maman E, Somjen D, Maman E, Katzburg S, Sharfman ZT, Stern N, Dolkart O. The response of cells derived from the supraspinatus tendon to estrogen and calciotropic hormone stimulations: in vitro study. Connect Tissue Res. 2016;57(2):124-30. doi: 10.3109/03008207.2015.1114615. Epub 2015 Dec 8.
PubMed 26646255Kearns MD, Alvarez JA, Tangpricha V. Large, single-dose, oral vitamin D supplementation in adult populations: a systematic review. Endocr Pract. 2014 Apr;20(4):341-51. doi: 10.4158/EP13265.RA.
PubMed 24246341Moon AS, Boudreau S, Mussell E, He JK, Brabston EW, Ponce BA, Momaya AM. Current concepts in vitamin D and orthopaedic surgery. Orthop Traumatol Surg Res. 2019 Apr;105(2):375-382. doi: 10.1016/j.otsr.2018.12.006. Epub 2019 Mar 8.
PubMed 30858042Entezari V, Lazarus M. Surgical Considerations in Managing Osteoporosis, Osteopenia, and Vitamin D Deficiency During Arthroscopic Rotator Cuff Repair. Orthop Clin North Am. 2019 Apr;50(2):233-243. doi: 10.1016/j.ocl.2018.10.006.
PubMed 30850081Reider B. Big D. Am J Sports Med. 2014 Jan;42(1):25-6. doi: 10.1177/0363546513516922. No abstract available.
PubMed 24384917
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 Supplementation vs Placebo for Vitamin D Deficient/Insufficient Patients Undergoing Arthroscopic Rotator Cuff Repair: a Quadruple-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05009498
- Acronym / sponsor ID
- VITD3RCR
- Conditions
- Vitamin D Deficiency, Rotator Cuff Tears
- Keywords
- Rotator Cuff repair, Rotator Cuff tears, Vitamin D deficiency, Vitamin D3 supplementation, Shoulder arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Community Memorial Health SystemUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rotator cuff injuries are the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Rotator cuff repair has long been the mainstay of treatment for symptomatic full-thickness tears and medium to large partial thickness tears that do no improve with nonoperative therapies.
Approximately 32% of the US population is Vitamin D deficient. This is important for many health reasons, but specifically, Vitamin D has been found to play a critical role in bone mineralization and fracture healing/prevention. There is emerging data to support Vitamin D's role in regulating the inflammatory response throughout the body, which includes soft tissue (i.e. tendons) healing. The role of Vitamin D in tendon to bone healing has yet to be fully investigated, yet it is reasonable to conclude that normal blood levels of Vitamin D would optimize the setting for healing in rotator cuff repair.
The investigators hypothesize that Vitamin D deficient patients undergoing shoulder rotator cuff repair will experience more positive outcomes and decreased complications when supplemented with Vitamin D3, compared to Vitamin D deficient patients who do not receive supplementation. The objective of this study is to demonstrate the positive effect of Vitamin D3 in rotator cuff repair healing and patient reported outcomes in patients who are Vitamin D deficient
Detailed description
Rotator cuff pathology is the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Incidence increases in a direct relationship to age. It is reported that over the age of 60, 28% of patients had full-thickness tears and 26% had partial thickness tears. Increasing age, history of trauma and hand dominance are associated risk factors for rotator cuff tearing. Rotator cuff tears (RCT) can occur from a degenerative process that increases with age, but also associated with micro- or macrotrauma. Rotator cuff repair (RCR) has long been the mainstay treatment for symptomatic full-thickness tears and medium to large partial thickness tears that have failed conservative measures. Long term clinical results for rotator cuff repair exceed 90% good to excellent results at 10 years.
According to the National Center for Health Statistics, approximately 32% of the US population is Vitamin D deficient. It has been widely accepted and studied that Vitamin D (25OHD) plays an important role in bone mineralization and fracture healing/prevention. Also, numerous studies have discovered the association of Vitamin D insufficiency with non-skeletal conditions such as Type 2 diabetes mellitus, cardiovascular disease, chronic pulmonary disease, tuberculosis, and upper respiratory conditions. There is an emerging focus on the role of Vitamin D and soft tissue healing and function.
Vitamin D decreases inflammation in the body by downregulating TNF alpha, which in turn decreases the amount of MMP-9 secreted. Increased MMPs have been associated with poor healing in rotator cuff muscles. Vitamin D levels have also been shown to affect the expression of BMPs, TGF-beta, and RANK.
Vitamin D receptors have been discovered on important soft tissue structures including tendons. It has been posited that Vitamin D's effect on regulating the inflammatory response is associated with tendon healing and overall function.
Traditional oral dosing for Vitamin D is in the Vitamin D3 form. Dosing quantities range from 400 IU to 5000 IU/day. In significantly deficient patients, it is not uncommon to see 50,000 IU/week for several weeks to achieve normal serum Vitamin D levels.
Studies have shown that the human body will generate up to 10,000-25,000 IU/day from sun exposure. This finding, among others, has called into question the arbitrary values set by IOM/ES to quantify serum levels for Vitamin D sufficient, insufficiency, or deficiency. Also, the daily recommended dosing quantities.
Vitamin D repletion therapy has been shown to be effective but often over protracted courses with no distinct linear relationship with the current recommendations set by the IOM/ES. Kerns et al 2014 performed the most comprehensive meta-analysis review of single, high-dose vitamin D supplementation and subsequent efficacy and safety. Their conclusion was that single vitamin D dosing of > 200,000 IU was able to sustain mean 25(OH)D concentrations > 30 ng/mL and there were no adverse effects noted at doses < 200,000. They also showed in all studies that peak serum 25(OH)D occurred at days 3-7. Some studies that examined single dose of 100,000 IU failed to achieve a serum 25(OH)D level of sufficiency for patients with baseline 25(OH)D of < 20ng/mL, and there were some reported adverse effects in single dose quantities of 300,000 to 600,000 IU (possible increased fracture risk, elevated bone turnover, transient serum hypercalcemia (> 500,000), and GI irritability).
With the prevalence of RCT and Vitamin D deficiency in the population, it is only reasonable to conclude that addressing the underlying biochemical processes to enhance soft tissue healing would provide a more favorable environment in the setting of rotator cuff repair. Orthopedic surgeons seek to optimize patient care by exhausting all available, and albeit reasonable, controllable variables The investigators hypothesize that Vitamin D deficient patients undergoing shoulder rotator cuff repair will experience more positive outcomes and decreased complications when supplemented with Vitamin D3, compared to Vitamin D deficient patients who do not receive supplementation.
The objective of this study is to demonstrate the positive effect of Vitamin D3 supplementation in rotator cuff repair healing and patient reported outcomes in patients who are Vitamin D deficient.
This is a prospective, quadruple-blinded, randomized, placebo-controlled study to evaluate the feasibility and effect of Vitamin D3 supplementation in Vitamin D deficient patients undergoing rotator cuff repair. Patients will be randomized to one of two arms, either Vitamin D3 supplementation or placebo. Each patient will be given a loading dose of 150,000 IUs prior to surgery, and then a bi-monthly maintenance dose of 50,000 IUs for one year. The patients will be followed for a total of 24 months following surgery. Clinical evidence of rotator cuff repair and patient reported outcome measures will be evaluated by chart review and patient questionnaires. All post-operative standard of care practices including laboratory tests, imaging, and rehabilitation will also be collected.
Enrollment will close once enough patients have been enrolled to achieve a 95% power. The investigators expect the study to take 2-3 years to complete.
Patients that meet all of the inclusion criteria and none of the exclusion criteria will be approached by the investigators, informed of the study, and provided with an informed consent form (ICF). Ample time will be given to the patient to review the ICF form in it's entirely and ask the investigator any questions they may have. If the patient agrees to participate, the will be asked to sign the ICF and the investigator obtaining consent will countersign. Patients will receive a copy of the signed consent form for their records, and the ICF will be scanned into the patient's medical record. The original paper copy of the ICF will be stored in a locked cabinet in the investigator's office. No data will be collected prior to completion of the informed consent form.
Once consent has been obtained, each participant will be assigned a subject ID number (ex. Subject # XXX). Baseline data will then be collected from the patient and their medical chart. These data points include: demographics, medical history, injury details, and rotator cuff tear pattern and location. A baseline patient reported outcomes questionnaire will also be obtained.
Feasibility of this study will be assessed over 24 months. Vitamin D3 and placebo will be administered over the course of the first 12 months of the study. Supplementation will begin between 3 and 7 days prior to the day of surgery, depending on the pre-operative scheduled appointment and relation to the day of surgery. The study participants will be expected to store and administer their scheduled dosing as instructed by the study team. Reminders prompting the patient's scheduled dosing will be sent via text and/or email, depending on patient preference as indicated on the initial questionnaire.
The loading dose and first maintenance dose following surgery will be administered to the patient at the study site. The bottle will then be provided to the participant for their personal storage and they will be instructed to take one 50,000 IU capsule (or identical placebo) once every two weeks for a total of 25 weeks (one year of total supplementation).
To ensure compliance, the participant will be asked to bring their bottle with them to each follow-up visit. At the 12 month follow-up visit, the participants will return their bottle to either the investigator or clinical research coordinator. If the participant does not return the bottle, the clinical research coordinator will provide them with an envelope to return it via mail.
Pre-operative labs will be ordered as standard of care and the results will be collected from the medical chart. Laboratory tests to be drawn are a comprehensive metabolic panel (CMP), serum 25(OH)D level, and complete blood count (CBC).
The study protocol does not dictate the surgical technique. Based on the study's eligibility criteria, all participants must receive tear pattern specific arthroscopic rotator cuff repair utilizing the double row versus single row technique. The orientation and final repair construct will be determined intraoperatively to the discretion of the treating surgeon. Surgical debridement, biceps tenotomy with or without tenodesis, and other surgical procedures will be performed as indicated for the benefit of the patient.
Details of the surgical management of the patient's rotator cuff tear will be collected from the medical record. Post-operative laboratory tests will be drawn per standard of care and collected from the medical record.
Post-operative rehabilitation will consist of sling utilization starting from post-operative day zero through week six, as per standard of care. Patients will be instructed on early passive range of motion (ROM) exercises (i.e. pendulum exercises) that will begin at the discretion of the treating surgeon. A recent study from AJSM (Keener et al, 2014) demonstrated no significant difference between early passive ROM vs 6 weeks of sling immobilization. The patient will be instructed to avoid active ROM (aROM) of the operative shoulder for the first 6 weeks, but will be allowed to remove the sling for elbow/wrist/hand ROM and hygiene. Starting at week one, patients will begin formal outpatient physical therapy (PT) twice a week. From weeks 6-12 patients will begin PT guided initiated assisted active ROM and aROM of the shoulder. From months 3-4, initiated cuff, deltoid, and scapular stabilizer strengthening. From month 4 and on, patients will begin full activities between months 4 through 6 on the basis of individual progress.
Details of the patient's rehabilitation course will be collected from the medical record The investigator who is the operative orthopedic surgeon will monitor patient safety for each of their patients involved in the study. The surgeon will be responsible for reviewing adverse events, enrollment numbers, and medical compliance. All serious adverse events will be recorded and promptly submitted according to the appropriate hospital policy. All serious adverse events will also be promptly reported to the IRB as well.
Following completion of this study, participants may be un-blinded from their treatment group upon request.
The patient questionnaires will be the primary data collection tool for the study. Other data points will be collected from the electronic medical record. Data will be stored on an encrypted database on password protected computers at the study site, only accessible to the investigators and study personnel. Data will be recorded at the time of collection. Hardcopy questionnaires and informed consent forms will be retained for double verification in a locked cabinet only accessible to the study team.
Study documents will be held in strict confidence by the investigators and other study personnel, and all efforts will be made to maintain patient confidentiality as per standard HIPAA requirements. All data will be de-identified prior to dissemination.
In accordance with 42 CFR 164.530(j)(2), all study records will be securely retained by the investigators for a minimum of 6 years following completion of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: PlaceboPatient will receive a placebo dosing, identical in appearance and at the same intervals as the interventional dose |
| Vitamin D3 supplementation group | Active comparator | Dietary Supplement: Vitamin D3 supplementationPatient will receive high-dose Vitamin D3 supplementation in capsule form, identical in appearance and at the same intervals as the placebo dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute or chronic rotator cuff tear
- Small to medium sized rotator cuff tear
- Rotator cuff tear which can be treated with arthroscopic RCR (single or double row technique)
- Serum 25(OH)D levels < 30 ng/mL
Key exclusion criteria (10 listed)
- Massive rotator cuff tear that is inoperable or requires superior capsular reconstruction (SCR)
- Revision RCR
- Serum 25(OH)D levels ≥ 30 ng/mL
- Elevated serum calcium (> 10.5 mg/dL)
- Known or likely undiagnosed disorders of bone metabolism (i.e. Pagets, ostemalacia, osteopetrosis, OI, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 supplementationVitamin D3 in 50,000 IU capsules Loading dose of 150,000 IUs (3 capsules) Interval dosing of 50,000 IUs (1 capsule) every 2 weeks for 1 year | Dietary supplement | Vitamin D3 supplementation group |
| PlaceboPlacebo capsule, identical in appearance to the Vitamin D3 supplement capsule Dosing intervals identical in duration and quantity as Vitamin D3 supplement group | Other | Placebo group |
Primary outcome
University of California-Los Angeles Shoulder score
Time frame: Baseline (Preop)
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Constant-Murray Shoulder Score
Time frame: Baseline (Preop)
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
American Shoulder and Elbow Surgeon score
Time frame: Baseline (Preop)
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
SF-12 (12-item Short Form Survey)
Time frame: Baseline (Preop)
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
University of California-Los Angeles Shoulder score
Time frame: 6 weeks post op
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Constant-Murray Shoulder Score
Time frame: 6 weeks post op
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
American Shoulder and Elbow Surgeon score
Time frame: 6 weeks post op
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
SF-12 (12-item Short Form Survey)
Time frame: 6 weeks post op
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
University of California-Los Angeles Shoulder score
Time frame: 12 weeks post op
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Constant-Murray Shoulder Score
Time frame: 12 weeks post op
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
American Shoulder and Elbow Surgeon score
Time frame: 12 weeks post op
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
SF-12 (12-item Short Form Survey)
Time frame: 12 weeks post op
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
University of California-Los Angeles Shoulder score
Time frame: 6 months post op
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Constant-Murray Shoulder Score
Time frame: 6 months post op
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
American Shoulder and Elbow Surgeon score
Time frame: 6 months post op
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
SF-12 (12-item Short Form Survey)
Time frame: 6 months post op
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
University of California-Los Angeles Shoulder score
Time frame: 12 months post op
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Constant-Murray Shoulder Score
Time frame: 12 months post op
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
American Shoulder and Elbow Surgeon score
Time frame: 12 months post op
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
SF-12 (12-item Short Form Survey)
Time frame: 12 months post op
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
University of California-Los Angeles Shoulder score
Time frame: 24 months post op
Shoulder scoring system mainly consisting of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 35, with a higher score indicating a better function.
Constant-Murray Shoulder Score
Time frame: 24 months post op
Shoulder score system mainly consisting of two parts. Patients subjectively evaluate pain and activity level; doctors objectively evaluate shoulder joint range of motion and muscle strength. Scores range from 0 to 100, higher score indicating better function. Compare to contralateral (unaffected shoulder).
American Shoulder and Elbow Surgeon score
Time frame: 24 months post op
Evaluation criteria used to assess shoulder joint function based on the patient's pain and accumulated daily activities. Possible scores range from 0 to 100, higher scores indicating better shoulder function.
SF-12 (12-item Short Form Survey)
Time frame: 24 months post op
A general health questionnaire, drawn from the original SF-36 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 24131579Angeline ME, Ma R, Pascual-Garrido C, Voigt C, Deng XH, Warren RF, Rodeo SA. Effect of diet-induced vitamin D deficiency on rotator cuff healing in a rat model. Am J Sports Med. 2014 Jan;42(1):27-34. doi: 10.1177/0363546513505421. Epub 2013 Oct 16.
- Background: PubMed 19949122Oh JH, Kim SH, Kim JH, Shin YH, Yoon JP, Oh CH. The level of vitamin D in the serum correlates with fatty degeneration of the muscles of the rotator cuff. J Bone Joint Surg Br. 2009 Dec;91(12):1587-93. doi: 10.1302/0301-620X.91B12.22481.
- Background: PubMed 25868637Ryu KJ, Kim BH, Lee Y, Dan J, Kim JH. Low Serum Vitamin D Is Not Correlated With the Severity of a Rotator Cuff Tear or Retear After Arthroscopic Repair. Am J Sports Med. 2015 Jul;43(7):1743-50. doi: 10.1177/0363546515578101. Epub 2015 Apr 13.
- Background: PubMed 31579883Harada GK, Arshi A, Fretes N, Formanek B, Gamradt S, McAllister DR, Petrigliano FA. Preoperative Vitamin D Deficiency Is Associated With Higher Postoperative Complications in Arthroscopic Rotator Cuff Repair. J Am Acad Orthop Surg Glob Res Rev. 2019 Jul 3;3(7):e075. doi: 10.5435/JAAOSGlobal-D-19-00075. eCollection 2019 Jul.
- Background: PubMed 27366101Dougherty KA, Dilisio MF, Agrawal DK. Vitamin D and the immunomodulation of rotator cuff injury. J Inflamm Res. 2016 Jun 14;9:123-31. doi: 10.2147/JIR.S106206. eCollection 2016.
- Background: PubMed 26646255Maman E, Somjen D, Maman E, Katzburg S, Sharfman ZT, Stern N, Dolkart O. The response of cells derived from the supraspinatus tendon to estrogen and calciotropic hormone stimulations: in vitro study. Connect Tissue Res. 2016;57(2):124-30. doi: 10.3109/03008207.2015.1114615. Epub 2015 Dec 8.
- Background: PubMed 24246341Kearns MD, Alvarez JA, Tangpricha V. Large, single-dose, oral vitamin D supplementation in adult populations: a systematic review. Endocr Pract. 2014 Apr;20(4):341-51. doi: 10.4158/EP13265.RA.
- Background: PubMed 30858042Moon AS, Boudreau S, Mussell E, He JK, Brabston EW, Ponce BA, Momaya AM. Current concepts in vitamin D and orthopaedic surgery. Orthop Traumatol Surg Res. 2019 Apr;105(2):375-382. doi: 10.1016/j.otsr.2018.12.006. Epub 2019 Mar 8.
- Background: PubMed 30850081Entezari V, Lazarus M. Surgical Considerations in Managing Osteoporosis, Osteopenia, and Vitamin D Deficiency During Arthroscopic Rotator Cuff Repair. Orthop Clin North Am. 2019 Apr;50(2):233-243. doi: 10.1016/j.ocl.2018.10.006.
- Background: PubMed 24384917Reider B. Big D. Am J Sports Med. 2014 Jan;42(1):25-6. doi: 10.1177/0363546513516922. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bogard, DO principal investigator
Community Memorial Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 supplementation in people with Vitamin D Deficiency and Rotator Cuff Tears, run by Community Memorial Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Bogard, DO ((714) 465 - 7064, mbogard@cmhshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of California-Los Angeles Shoulder score (time frame: Baseline (Preop)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009498, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.